FDA.reportPublic FDA data

uTASWako AFP-L3 Sample Dilution Buffer

Primary DI
04987481164468
Brand
uTASWako AFP-L3 Sample Dilution Buffer
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
997-61501
Catalog number
997-61501
Device description
In-Vitro Diagnostic Use
Published
2020-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSFTest, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk AssessmentImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100464000UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONWako Chemicals USA, Inc.2011-02-23NSF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856626006189PreviousGS10
14987481164465PrimaryGS10
04987481164468Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1085662600618910856626006189
1498748116446514987481164465
04987481164468049874811644684987481164468

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to qualitatively and/or quantitatively detect alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-323-5300fmsuregulatoryaffairs@fujifilm.com

Regulatory Flags#

DUNS number
690598875
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987481164666Autokit Micro Albumin999-06001999-060012021-07-30
04987481164673Autokit Micro Albumin Control Set991-06201991-062012021-06-01
14987481164427uTASWako Chip Cassette993-61601993-616012020-10-23
14987481164465uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012020-10-23
10856626006080uTASWako Chip Cassette993-61601993-616012016-11-11
10856626006189uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012016-12-22
04987481164680uTASWako i30991-60301991-603012020-10-23
00856626006229uTASWako i30991-60301991-603012020-06-01
14987481164557HDL-C/LDL-C Calibrator990-28011990-280112020-10-23
14987481164564L-Type HDL-C Reagent 1991-00101991-001012020-10-23
14987481164571L-Type HDL-C Reagent 2997-00201997-002012020-10-23
14987481164588L-Type HDL-C Reagent 1997-72591997-725912020-10-23
14987481164595L-Type HDL-C Reagent 2993-72691993-726912020-10-23
10856626006035HDL-C/LDL-C Calibrator990-28011990-280112016-12-07
10856626006042L-Type HDL-C (Reagent 1) 991-00101991-001012016-11-11
10856626006097L-Type HDL-C Reagent 2993-72691993-726912016-11-23
10856626006141L-Type HDL-C (Reagent 2)997-00201997-002012016-11-11
10856626006196L-Type HDL-C Reagent 1997-72591997-725912016-11-23
14987481164533L-Type LDL-C Reagent 1999-00404999-004042021-06-01
14987481164540L-Type LDL-C Reagent 2999-00504999-005042021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14987481164427uTASWako Chip CassetteFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
14987481164465uTASWako AFP-L3 Sample Dilution BufferFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
14987481164502uTASWako Wash SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
04987481164390uTASWako AFP-L3FUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
04987481164420uTASWako Chip CassetteFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
04987481164505uTASWako Wash SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2020-10-23
10856626006189uTASWako AFP-L3 Sample Dilution BufferFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2016-12-22
10856626006059uTASWako Wash SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2016-12-07
00856626006205uTASWako AFP-L3FUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2016-12-07
10856626006080uTASWako Chip CassetteFUJIFILM WAKO PURE CHEMICAL CORPORATIONNSF2016-11-11